NCT01568203

Brief Summary

The purpose of this study is to assess the safety and tolerability of AMG 579 following a single oral dose administration in healthy subjects (Part A) and in patients with schizophrenia or stable schizoaffective disorder (Part B). The study in healthy subjects (Part A) concluded, and following a protocol amendment, enrolled only patients with schizophrenia or stable schizoaffective disorder (Part B).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 schizophrenia

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

9 months

First QC Date

February 27, 2012

Last Update Submit

October 5, 2012

Conditions

Schizophrenia

Keywords

single dose, safety, healthy subjects, schizoaffective disorder, AMG 579

Outcome Measures

Primary Outcomes (2)

  • Number of adverse events per subject to include clinically significant changes in neurological examinations, safety laboratory tests, electrocardiograms, and vital signs

    Up to 15 days

  • Incidence of treatment-emergent suicidal ideation and behavior

    Measured by Columbia-Suicide Severity Rating Scale (C-SSRS)

    Up to 15 days

Secondary Outcomes (5)

  • Peak plasma and cerebrospinal fluid (CSF; cohort 4 healthy subjects only) concentration (Cmax) of AMG 579

    Up to 15 days

  • Time of peak plasma and CSF (cohort 4 only healthy subjects only) concentration (tmax) of AMG 579

    Up to 15 days

  • Area under the plasma and CSF (cohort 4 healthy subjects only) concentration versus time curve (AUC) of AMG 579

    Up to 15 days

  • Terminal phase half-life (t1/2) in plasma and CSF (cohort 4 healthy subjects only) of AMG 579

    Up to 15 days

  • Scores on Simpson Angus Scale (SAS) and Barnes Akathesia Rating Scale (BARS)

    Up to 15 days

Study Arms (2)

AMG 579

EXPERIMENTAL
Drug: AMG 579

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AMG 579DRUG

3 dose levels of single oral dose administration of AMG 579 in healthy subjects (Part A), and 5 dose levels of single oral dose administration of AMG 579 in patients with schizophrenia or schizoaffective disorder (Part B)

AMG 579
PlaceboDRUG

Matching placebo control for AMG 579 at each dose level

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of schizophrenia (chronic, all types) or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition Text Revision (DSM-IV-TR) criteria and by Mini International Neuropsychiatric Interview (M.I.N.I.) 6.0 for Schizophrenia and Psychotic Disorders Studies
  • Body weight greater or equal to 50 kg and body mass index (BMI) between 18 and 38.0 kg/m2, inclusive, at screening
  • Patient is judged by the Investigator to be likely to tolerate being off of antipsychotic medications for the duration of the trial (for patients withdrawing from or currently not taking antipsychotic medications)
  • Clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks within enrollment. If patient is on antipsychotic medications, they must be on second generation oral antipsychotic therapy (eg, ziprasidone, quetiapine, olanzapine, etc) for at least 8 weeks within enrollment and at least one month within enrollment on a stable dose

You may not qualify if:

  • Hospitalized for psychiatric symptoms in the 3 months within enrollment
  • Patients with evidence of mental retardation by history or clinical examination or known premorbid IQ ≤ 70
  • Current risk of self-harm or violence as determined by the investigator, or current risk of suicide or history of suicidal behavior within 12 months of enrollment, and/or ongoing suicidal ideation as assessed using Columbia-Suicidal Severity Rating Scale (C-SSRS) at screening (eg, any response of "yes" to the Suicidal Ideation questions on the C-SSRS in the past 12 months).
  • Additional critera apply. Eligibility criteria for healthy subjects (Part A) not outlined above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Glendale, California, 91206, United States

Location

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

1-(4-(3-(4-(1H-benzo(d)imidazole-2-carbonyl)phenoxy)pyrazin-2-yl)piperidin-1-yl)ethanone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2012

First Posted

April 2, 2012

Study Start

September 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

US(1)